Senior Systems Engineer

Description

The company is a publicly traded medical technology business (HTFL) focused on diagnosing and managing coronary artery disease, the leading cause of death worldwide.

Its main product is a non-invasive, AI-driven cardiac test that builds a color-coded 3D model of a patient's coronary arteries and shows how blockages affect blood flow to the heart.

The product line covers identifying stenoses, assessing coronary blood flow and characterizing plaque across the CCTA pathway, and it is expanding along with the team.

The products are cleared for use in the US, UK, Europe, Japan and Canada, are supported by medical societies worldwide, and have been used for more than 750,000 patients.

This role owns the completeness and quality of system-level design and documentation for the core products. You will turn user needs and product requirements into technical requirements that can be built, own the functional architecture, and work with R&D to keep the design traceable, testable and sustainable.

Responsibilities

• Define system requirements and keep the functional architecture current, covering the major subsystems, what each must do, and the interfaces and data flows between them.
• Own the system-level verification and validation strategy: decide what gets verified or validated and at which level, and identify the evidence that confirms each requirement.
• Maintain traceability from user needs to requirements and on to verification and validation evidence as the system changes.
• Work with the System Test and Software Engineering teams to make requirements clear and testable.
• Find and resolve complex technical problems across system boundaries, and coordinate dependencies between engineering disciplines.
• Identify, analyze and reduce technical and product risks, and support failure investigations, root cause analysis, corrective actions and reliability and performance assessments.
• Weigh trade-offs among performance, safety, usability, reliability, scalability, maintainability, schedule and cost, then use data and engineering judgment to recommend solutions and drive decisions.
• Act as technical lead across software, algorithm, quality, regulatory, clinical, product and operations teams, from concept development through software release and post-market surveillance.
• Improve systems engineering practices across the organization, including requirements management, risk management, verification planning, traceability and development lifecycle processes, and mentor systems engineers as the team grows.

Requirements

• A Bachelor's, Master's or PhD in systems engineering, computer science, biomedical engineering or a related field.
• 8+ years of industry experience in systems engineering or a related role building complex software-enabled products.
• Hands-on experience defining functional architectures, requirements, specifications and interfaces.
• A proven record of integrating multidisciplinary systems, analyzing hard technical problems, performing root cause analysis and closing issues.
• Experience defining system-level verification strategies and reviewing test plans and results for requirement coverage, plus working knowledge of product risk management and design controls.
• Working knowledge of IEC 62304, including how it governs the medical device software lifecycle, software safety classification and lifecycle documentation.
• Ability to make and explain sound technical recommendations that balance user needs, safety, performance, reliability, quality, schedule and cost.
• Experience leading technical discussions, influencing decisions and working across software, algorithms, quality, regulatory, clinical, product and operations teams.
• Strong written and verbal communication, with the ability to explain complex technical concepts to technical and non-technical audiences.
• Experience with requirements management, issue tracking, documentation or product lifecycle management tools such as Jira or Ketryx.
• Preferred: familiarity with Python or similar tools for analysis and automation.
• Preferred: experience developing FDA-regulated SaMD or medical imaging systems, including contributing to regulatory submissions.
• Preferred: experience with cardiovascular imaging, CT, CCTA or clinical software workflows.
• Preferred: experience with Model-Based Systems Engineering (MBSE), system modeling or formal architecture methods.
• Preferred: familiarity with ISO 14971, ISO 13485 or comparable risk and quality management standards.
• Preferred: INCOSE certification (ASEP or CSEP) or demonstrated fluency with INCOSE requirements-writing practices.
• Preferred: familiarity with FDA premarket cybersecurity guidance and secure development practices such as SBOM and threat modeling for connected SaMD.

Conditions

The estimated base salary range is $180,000 to $215,000, with bonus and equity also part of the compensation.

The company is an equal opportunity employer and prohibits discrimination in every aspect of employment on any legally protected basis.